1+ months

/Drug Substance Upstream Technician

Pfizer
Plant City, FL 33563
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**** **Role Summary**

WAVEXDRcGMP



Participate in the execution of drug substance upstream cell culture processes, include but are not limited the following activity: the media preparation, cell bank vial thaw, shake flask inoculation, WAVE bioreactor operation, XDR bioreactor operation and continue centrifuge operation. Execute manufacturing and qualification/validation activity, including product operations, suite clearance and changeover, equipment processing, solution formulation, manufacturing batch record review and special sample coordination. Provide support in troubleshooting activities, technology transfer and start-up activities. Support superviser to execute investigations, analyze process data and identify and implement process improvements. Provide support of process of experimental design with regard to system mixing, mass transfer, and other pertinent aspects of bioprocess system control. Author and present comprehensive technical presentations and procedures. Thorough understanding of cGMP requirements and safety practices and provide audit support to several internal and external audits.



**** **Role Responsibilities**



+ SOPWAVEXDR



Perform DS upstream cell culture manufacturing under standard operation procedure, include but are not limited the following activity: the media preparation, cell bank vial thaw, shake flask inoculation, WAVE bioreactor operation, XDR bioreactor operation and continue centrifuge operation..



+ SOP



Perform standard operating procedures of DS upstream cell culture startup/scale up/clinical lots production in new facility.



+ SOP



Author documentation such as batch records, procedures, and validation reports as directed by supervisor.



+



Provide real-time RFT support of critical operations.



+



Work with supervisor to communicate and resolve operational variances.



+ /



Process monitoring including real time review of process parameters and process data/trend analysis.



+



Communicate process performance across shifts and departments.



+



Support supervisor to Implement process enhancements, measure and respond to equipment capability and implement new technologies.



+



Execute operation following QEHS regulations.



+



Participate investigations, and change controls to ensure changes are value added and processes and equipment are robust.



+



Participate a culture of Innovation and Continuous improvement. Drive changes that support Right First Time, Efficiency, and/or reduced costs.



+



Provide Audit support.



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Execute other items assigned by supervisor.



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Attend shift work according to manufacturing requirement.



**** **Qualification ( Minimum Requirements)**

/ Education/Experiences



+



BS or MS in chemical engineering, biology, biochemistry or other related science or engineering field.



+



Experience working in related environment is a plus.



/ Specific Knowledge & Skills



+



Good English oral and written communication skills are required.



+



Familiarity with mammalian cell culture. Solution formulation is not essential, but is highly desirable.



+ GMP



Familiarity and experience with a GMP manufacturing environment is a plus.



+



Familiarity with manufacturing-scale bioreactors/fermenters, centrifuge is a plus.



+ 65s



Experience with Six Sigma, Method 1, 5S and/or other operational excellence programs a plus.



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



Manufacturing
Posted: 2020-03-16 Expires: 2020-06-18
Sponsored by:
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/Drug Substance Upstream Technician

Pfizer
Plant City, FL 33563

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